End-Tidal Gas Estimation System and Method

ABSTRACT

An apparatus and method of indicating the reliability of an end-tidal gas value that includes measuring a plurality of gas concentration values, measuring a plurality of ventilation values, determining an end-tidal gas value from the gas concentration values, determining the degree of ventilatory stability from the ventilation values, and providing an estimate of reliability of the end-tidal gas values using the degree of ventilatory stability.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) fromprovisional U.S. patent application No. 60/918,189, filed Mar. 17, 2007,the contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention pertains to a method and apparatus for providing areliable end-tidal carbon dioxide (CO₂), end-tidal oxygen (O₂), or othergas estimation.

2. Description of the Related Art

Respiratory gas monitoring systems typically comprise gas sensing,measurement, processing, communication, and display functions. Suchsystems are considered to be either diverting (i.e., sidestream) ornon-diverting (i.e., mainstream). A diverting gas measurement systemtransports a portion of the sampled gases from the sampling site, whichis typically a breathing circuit or the patient's airway, through asampling tube, to the gas sensor where the constituents of the gas aremeasured. A non-diverting gas measurement system does not transport gasaway from the breathing circuit or airway, but measures the gasconstituents passing through the breathing circuit.

Conventional non-diverting gas measurement systems include gas sensing,measurement and signal processing required to convert the detected ormeasured signal (e.g., voltage) into a value that may be used by thehost system. The gas measurement system communicates with the samplecell placed at the breathing circuit and comprises the componentsrequired to output a signal corresponding to a property of the gas to bemeasured. Placement of the sample cell directly at the breathing circuitresults in a “crisp” waveform that reflects in real-time the partialpressure of the measured gas, such as carbon dioxide or oxygen, withinthe airway. The sample cell, which is also referred to as a cuvette orairway adapter, is located in the respiratory gas stream, obviating theneed for gas sampling and scavenging as required in a diverting gasmeasurement system.

Conventional diverting gas measurement systems utilize a relatively longsampling plastic tube connected to an adapter in the breathing circuit(such as a T-piece at the endotracheal tube or mask connector) or anasal catheter. The sample gas is continuously aspirated from thebreathing circuit or the sample site through the sampling tube and intothe sample cell within the monitor at sample flow rates ranging from 50to 250 ml/min. The location of the sampling port in the breathing variesand may range anywhere from an elbow connected to an endotracheal tubeto the wye connector.

Both diverting and non-diverting gas measurement systems include sensorsthat measure the concentration and/or partial pressure of at least oneof the gas components in the sampled gas passing through the samplecell. Two of the most commonly measured gases of clinical importance arecarbon dioxide and oxygen. Both diverting and non-diverting gasmeasurement systems utilize sensors to measure the constituent gasessuch as carbon dioxide and oxygen.

To measure these gases, electro-optical assemblies are often employed.In the case of a carbon dioxide sensor and a number of other gassensors, these assemblies includes a source that emits infraredradiation having an absorption band for carbon dioxide. The infraredradiation is usually transmitted along a path that is normal to the flowpath of the gas stream being analyzed. Photodetectors are arranged toreceive and measure the transmitted radiation that has passed throughthe gas in the gas stream. Carbon dioxide within the sample gas absorbsthis radiation at some wavelengths and passes other wavelengths. Thetransmitted radiation is converted to signals from which a processorcalculates the partial pressure of carbon dioxide. In the case of anoxygen sensor, electrochemical or fluorescence based technologies areoften employed.

Carbon dioxide and oxygen are expressed either as a gas fraction (FCO₂and FO₂) or partial pressure (PCO₂ and PO₂). Capnography and oxygraphy,when used without qualification, refers to time-based capnography andoxygraphy. In addition to capnometry, capnography includes a plot of theinstantaneous carbon dioxide concentration over the course of arespiratory cycle. From this plot, the cyclic changes can be visualized.

In a “textbook” capnogram 2, an example of which is shown in FIG. 1, thecapnogram comprises two segments: an “expiratory” segment 4, and an“inspiratory” segment 6. The expiratory segment consists of a varyingupslope 5 a that levels to a constant or slight upslope 5 b. Theinspiratory segment consists of a sharp downslope 7 a that settles to aplateau of negligible inspired carbon dioxide 7 b. However, other thanthe end-tidal partial pressure of carbon dioxide, which has beengenerally understood as the partial pressure of carbon dioxide at theend of expiration, only breathing frequency and a measure of inspiratorycarbon dioxide levels are clinically reported. This is the case becauseonly the transition between the expiratory and inspiratory segments canusually be well delineated from a capnogram.

Even then, only if there is substantially no rebreathing, does thistransition correspond to the time of the actual beginning of inspirationas delineated by the flow waveform. The transition between inspirationand expiration cannot be readily discerned because of the presence ofanatomic dead space that fills with inspiratory gas at the end ofexpiration. Although the oxygram is not in as widespread clinical use ascapnograph, the same issues discussed above apply to the oxygram withthe understanding that the oxygram can be considered an inverted versionof the capnogram.

If flow is measured in addition to carbon dioxide, the volumetriccapnogram can be determined. Similarly if flow is measured in additionto oxygen, the volumetric oxygram can be determined. FIG. 2 illustratesthe three phases of a volumetric capnogram. Phase I comprises the carbondioxide free volume, while phase II comprises the transitional regioncharacterized by a rapidly increasing carbon dioxide concentrationresulting from progressive emptying of the alveoli. Phases II and IIItogether are the carbon dioxide containing part of the breath, theeffective tidal volume, V_(T)eff. Phase III, the alveolar plateau,typically, has a positive slope indicating a rising PCO₂. Using thesethree phases of the volumetric capnogram, physiologically relevantmeasures, such as the volumes of each phase, the slopes of phase II andIII, and carbon dioxide elimination, as well as deadspace tidal volumeand ratios of anatomic and physiologic deadspace can be determined.

One of the objectives when setting the level of mechanical ventilationfor a patient is to reach and maintain a desired concentration ofarterial carbon dioxide concentration (PaCO₂). Because real-time accessto PaCO₂ measurements is not easy, estimates from a capnogram are usedto obtain a surrogate measure. Because of pulmonary shunting, i.e., aportion of the right heart cardiac output reaches the left atriumwithout having participated in gas exchange, the closest surrogate ofPaCO₂ that can be obtained from the capnogram is alveolar CO₂concentration (PACO₂).

The end-tidal partial pressure of CO₂ (PetCO₂), usually referred to asthe end-tidal carbon dioxide, is used clinically, for example, to assessa patient ventilatory status and, as noted above, has been used by someas a surrogate for PaCO₂. Similarly, the end-tidal partial pressure ofO₂(PetO₂), which may be referred to as the end-tidal oxygen, is alsoused.

The medical literature is replete with conflicting articles regardingthe relationship between PetCO₂ and PaCO₂, as well as the relationshipbetween changes in PetCO₂ and changes in PaCO₂. On one hand, Nangia etal. notes that “ETCO₂ correlates closely with PaCO₂ in most clinicalsituations in neonates”. Similarly, Wu et. al. notes that “we recommendusing mainstream capnography to monitor PetCO₂ instead of measuringPaCO₂ in the NICU.” On the other hand, Russell et al. studied ventilatedadults and noted “trends in P(a-et)CO₂ magnitude are not reliable, andconcordant direction changes in PetCO₂ and PaCO₂ are not assured.”

Researchers have considered maneuvers to improve ‘prediction’ of PaCO₂.Tavernier et al. studied whether prolonged expiratory maneuvers inpatients undergoing thoracoabdominal oesophagectomy improved theprediction of PaCO₂ from PetCO₂ and concluded that these maneuvers didnot improve estimation. A commonly held belief among critical carephysicians is that end-tidal CO₂ cannot be used as a surrogate foreither arterial PCO₂ or changes in arterial PCO₂. To complicate mattersfurther Chan et al. noted that “mainstream PetCO₂ provided a moreaccurate estimation of PaCO₂ than side-stream measurement.”

If end-tidal PCO₂ could be reliably used as a surrogate for arterialCO₂, arterial blood sampling could be reduced, applications thatcurrently use intermittent blood sampling would become more clinicallyacceptable, and applications, such as closed loop control of ventilation(particularly non-invasive ventilation), would be more viable.Therefore, techniques for reliability and/or indicating the reliabilityof end-tidal PCO₂ estimations are desired.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide amethod of indicating the reliability of an end-tidal gas value thatovercomes the shortcomings of conventional end-tidal CO₂ measurementtechniques. This object is achieved according to one embodiment of thepresent invention by providing a method of indicating the reliability ofan end-tidal gas value that includes measuring a plurality of gasconcentration values, measuring a plurality of ventilation values,determining an end-tidal gas value from the gas concentration values,determining the degree of ventilatory stability from the ventilationvalues, and providing an estimate of reliability of the end-tidal gasvalues using the degree of ventilatory stability.

It is a further object of the present invention to provide an apparatusthat indicates the reliability of an end-tidal gas value that overcomesthe shortcomings of conventional end-tidal CO₂ measurement techniques.This object is achieved according to one embodiment of the presentinvention by providing an apparatus comprising a means for sensing aplurality of gas concentration values, means for sensing a plurality ofventilation values, means for determining an end-tidal value from thegas concentration values, means for determining the degree ofventilatory stability from the ventilation values, and means forproviding an estimate of reliability of the end-tidal gas values usingthe degree of ventilatory stability.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and in the claims, the singular form of “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graph of an exemplary time-based capnogram;

FIG. 2 is a graph of an exemplary volumetric capnogram;

FIG. 3 is a schematic illustration of a gas measurement system inaccordance with an exemplary embodiment of the present invention;

FIG. 4 is a chart illustrating flow, pressure, and CO₂ measurements of apatient;

FIG. 5 is an exemplary time-based capnogram with a long expiratorypause;

FIG. 6 is exemplary volumetric capnogram of the waveform in FIG. 5;

FIG. 7 is a schematic diagram of an exemplary apparatus suitable forimplementing the process of the present invention;

FIGS. 8A and 8B are plots of simulated flow, volume, and alveolar CO₂concentrations;

FIG. 9A is a time based capnogram recorded with a mouthpiece, and FIG.9B is a time-based capnogram recorded with a face mask; and

FIG. 10 is a volumetric capnogram and an associated power regressionapproximation curve.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The present invention addresses the known problems with the studies todate including (a) the lack of a clear definition of end-tidal gasvalue, (b) how end-tidal gas values relate to arterial gas values inboth ‘stable’ and ‘unstable’ ventilatory patterns, and, (c) anunderstanding of when end-tidal gas values will and won't be a reliablecorrelate of arterial and or alveolar gas values. The present inventionaddresses the need to provide more reliable end-tidal gas values. Itshould be noted that the while most of the present discussion takesplace with reference to carbon dioxide (CO₂), the methods describedherein apply to other gases as well, including but not limited torespiratory gases, such as oxygen, nitrous oxide, nitric oxide, andother gases, such as anesthetic agents. To determine a more reliableend-tidal gas value, it is important to delineate properly the end-tidalgas value and to determine the reliability of that estimate.

An exemplary embodiment of a gas measurement system 10 suitable for usein the present invention is illustrated in FIG. 3. The illustratedexemplary embodiment of system 10 comprises a differential pressureflowmeter 12, a flow signal unit 16, a gas sensor 14, a CO₂ signal unit18, a processor or processing unit 20, and a data display 22. System 10can be used alone or in combination with mechanical ventilation of thepatient. It can be a stand-alone monitoring system or integrated with aventilator.

The exemplary device for respiratory flow measurement is differentialpressure flowmeter 12, which provides a pressure differential indicativeof respiratory flow; the differential pressure being converted viapressure transducers in flow signal unit 16 to electrical signalsrepresentative of the relationship between respiratory flow and pressuredifferential. An exemplary differential pressure flowmeter ismanufactured and sold by Respironics, Inc., Wallingford, Conn. However,any flow measurement devices may be utilized, including flow sensorsbased on other flow measurement techniques, such as optical, vanes,sonic, etc.

Sensors capable of measuring carbon dioxide content in a gas sample arewell known. An exemplary device for measuring carbon dioxide content isa gas analyzer of the type employing non-dispersive infrared radiation,which presents data representing the % CO₂ (or pCO₂) of a sample ofexhaled breath. Other technologies used to measure the concentration ofcarbon dioxide, such as electrochemical technologies, Ramanspectroscopy, and mass spectroscopy, can also be used in the presentinvention. The exemplary gas sensor 14 capable of measuring carbondioxide content in a patient's exhaled breath is available fromRespironics, Inc., Wallingford, Conn., under the trade name CAPNOSTAT®.It is to be understood, however, that other methods of measuring carbondioxide content, either at the airway (non-diverting) or by removing asample (diverting), may be used in the present invention.

FIG. 4 illustrates one of the problems determining a repeatable andreliable end-tidal value with a plot of flow 24, pressure, 26 and CO₂ 28as a function of time for two “breaths” with ventilator-patientasynchrony. The measured value of the PetCO₂ depends upon how PetCO₂value is defined. For example, depending on how end-tidal CO₂ isdetermined, it could be reported as either 27, 30 or 31 mm Hg. In FIG.4, PetCO₂ at position 82 is 27 mm Hg, at position 84 is 31 mm Hg, and atposition 86 is 30 mm Hg. The end of expiration, as defined by the flowwaveform (position 82), results in an end-tidal value of 27 mm Hg.However, using the apparent expiration-inspiratory transition-position86 from the capnogram alone results in PetCO₂ of 30 mmHg. On the otherhand, if the largest value is used (position 84) a PetCO₂ of 31 mm Hg isobtained.

Conventionally, the concentration towards the end of phase III of thetime or volumetric capnogram is considered the good estimator ofalveolar CO₂ concentration (i.e. PetCO₂) and is usually determined on abreath-by-breath basis. As noted earlier, the simplest approach todetermining PetCO₂ is simply to use the maximum value which wouldgenerally occur during phase III. Because extreme values are oftensensitive to artifact or noise, other approaches may use an average overthe last part of phase III, where the ‘last part’ can be defined eitherin terms of time or in terms of expiratory volume.

The present invention, unlike these other techniques, contemplates usingthe flow and/or pressure waveform to better delineate the end ofexpiration, especially, if significant rebreathing is present, so thatthe end-tidal gas value may be simply and repeatably determined.Similarly, because volume is the integral of flow, the volumetriccapnogram may also be used as well to better delineate the end ofexpiration (see below). If the flow waveform or a surrogate is notavailable, the present invention contemplates using a waveform shapeanalysis to better delineate the end of expiration.

FIGS. 5 and 6 are time-based and volumetric capnograms illustrating thepotential difficulty of obtaining an end-tidal value from a time basedcapnogram alone. FIG. 5 illustrates a phenomenon often seen in neonateswith long expiratory pauses due to the I:E ratios of 1:8-1:10 duringwhich very minor inspiratory efforts are made resulting in a capnogramthat is difficult to interpret. Examining such a time-based capnogrammakes it very difficult to determine an end-tidal value. However,comparing the time-based and volumetric-based capnograms in FIGS. 5 and6 allows for some clarity. Note that the ventilation-perfusionrelationships of the lung are more accurately reflected in the slope ofphase III by a volumetric capnogram than in that of a time-basedcapnogram in which the gradient of the phase III slope is usually lessobvious and can be misleading. This may be because a smaller volume ofexpired gases (approximately the final 15%) often occupies half the timeavailable for expiration, so that a similar change in the CO₂concentration is distributed over a greater length of time in thetime-based capnogram than in the volumetric capnogram.

In FIG. 6, the plot of the expired volume vs. the partial pressure ofCO₂ during expiration clearly shows a plateau 90 from which an end-tidalvalue may be determined using a variety of methods. All of theparameters associated with volumetric capnography can also bedetermined. For example, the end-tidal gas value may be determined bycomputing the average PCO₂ value for the last X % of volume (such as 5or 10%), fitting the curve, or a portion of it, to a model(physiologically based such as one based on Weibel model or empirical).Using a model based approach to fit the concentration-volume curveallows for potentially clinically relevant values to be determined.

In addition to the challenges already outline, one of the primarychallenges in the determination and clinical use of PetCO₂ values comesfrom an implied assumption, that PetCO₂ represents the average value ofthe alveolar CO₂ concentration (P_(A)CO₂). As CO₂ continues to pass fromthe blood into the alveolar gas phase during expiration, the alveolarCO₂ concentration rises during expiration. During inspiration, CO₂ freegas serves to dilute the alveolar gas and the alveolar CO₂ concentrationdecreases. The shape of the respiratory flow waveform (e.g., tidalvolume, inspiratory to expiratory time ratio), the pulmonary capillaryblood flow, the venous CO₂ concentration, the amount of deadspace, andthe serial and alveolar deadspace affect the particular shape of thealveolar CO₂ concentration waveform. This shape, in turn, affects theaverage alveolar CO₂ concentration. The very last part of the expiredvolume that leaves the lungs, never reaches gas sensor 14, but remainsin the anatomical and apparatus (serial) deadspace.

The simulation shown in FIGS. 8A and 8B, which show simulated flow 202,volume 204, and alveolar CO₂ concentration 206 waveforms illustrate howthis can affect the PetCO₂ and its relationship to average alveolar CO₂concentration. Lines 210 and 310 in alveolar CO₂ concentration graphs206 and 306 indicate the average alveolar concentration. Thickened lines220 and 320 of alveolar CO₂ concentration graphs 206 and 306 illustrateportions of the alveolar waveform that is measured by gas sensor 14 inthe form of a capnogram. End portions 221 and 321 of the thickened lines220 and 320 are conventionally reported as PetCO₂.

FIG. 8A illustrates the waveforms that would be observed if there was noserial deadspace between the alveoli and gas sensor 14. The resultingPetCO₂ value (end portion 221) would overestimate average alveolar CO₂in this simulation. FIG. 8B illustrates the waveforms which would beobserved if there was a normal serial deadspace (e.g., 150 ml) betweenthe alveoli and gas sensor 14. The resulting PetCO₂ value (end portion321) would underestimate average alveolar CO₂ in this simulation. Thestep size of the alveolar CO₂ concentration graphs 206 and 306 areapproximately 4 mmHg. Larger deadspaces and smaller tidal volumes canincrease the difference between PetCO₂ and average alveolar CO₂concentration. Also, this effect may increase noise in PetCO₂ signal dueto breath-to-breath variations in tidal volumes of spontaneouslybreathing patients.

In patients who breathe through a face mask (instead of an endotrachealtube), the capnogram is additionally affected by the “smearing” effectof the face mask volume—again exacerbated by small or varying tidalvolumes. This “smearing” effect is shown in FIGS. 9A and 9B. In FIG. 9A,the patient is breathing with through a mouthpiece resulting in alphaangle 410 of capnogram 405, which is only slightly larger than 90degrees. In addition, capnogram 405 has as a relatively flat phase III.In FIG. 9B, the same patient is breathing through a face mask resultingin alpha angle 420 of capnogram 415 that is more obtuse than angle 410.In addition, phase III of capnogram 415 is more rounded than incapnogram 405, primarily due to the dilution and mixing in the deadspacevolume of the face mask. Generally, the differences between PetCO₂ andaverage alveolar CO₂ concentration are relatively small in most subjects(e.g., on the order of 2 or 3 mmHg) without seriousventilation-perfusion abnormalities. If, however, PetCO₂ is used toextract additional information, such as with partial CO₂ rebreathingmaneuvers, these small differences may become significant.

The present invention contemplates approximating expiratory volumetriccapnograms using mathematical functions. This is especially helpful whenattempting to obtain a capnogram under adverse conditions, such as thosenoted above, as well as in the presence of large noise (physiologicaland instrumental). An exemplary mathematical function that may be usedto approximate an expiratory volumetric capnogram is a power function ofthe following form:

invCO₂ =f×V _(E) ^(n),

where: invCO₂═CO₂−maxCO₂, CO₂ is the expired CO₂ as measured by the gassensor, V_(E) is the expired volume, f and n are approximationparameters, and maxCO₂ is constant CO₂ value, which is anotherapproximation parameter.

The approximation parameters f and n can be found by known numericalmethods, including linear regression of natural log (invCO₂) vs naturallog (VE). The approximation parameter maxCO₂ can be found iterativelyusing known search algorithms or using more generalized least-squaresalgorithms than conventional linear regression.

FIG. 10 shows an example of an original capnogram 510 approximated by apower regression curve 520. A number of approaches are contemplated todetermine an PetCO₂-equivalent value from this power regressionapproximation. In general, the PetCO₂ value should be morerepresentative of the alveolar CO₂ concentration, if the tidal volume islarge. If the tidal volume is small, the power regression approximationmay be used to extrapolate to what the capnogram value would have beenat a larger expiratory volume. Alternatively, the power regressionapproximation may be used to report the PetCO₂ concentration at oneconstant expired volume for all breaths, regardless whether they aresmall or large.

The present invention contemplates that the model derived PetCO₂ valuescould be used replace conventionally determined PetCO₂ values inconventional CO₂ monitors, as well as replace conventionally determinedPetCO₂ values for differential CO₂ Fick determination of pulmonarycapillary blood flow. Other approximation functions, other than thepower function described above, are contemplated as well. Theapproximation parameters may be found by methods known in the artincluding, but not limited to, linear regression, least squarealgorithms, artificial neural networks and iterative search algorithms.The algorithm to find the approximation parameters may also considerapproximation results from previous breaths to make finding theapproximation parameters for the current breath faster, lesscomputationally expensive, and more accurate.

The present invention contemplates providing a better definition of whenend-tidal CO₂, however it may be determined, is a reliable/viableestimate of arterial CO₂ and when it is not a reliable/viable estimateof arterial CO₂. This may be related to both the physiological status ofthe patient's cardio-pulmonary system and the recent pattern ofventilation, which may have significantly affected the lung and bloodstores of the patient. Therefore, estimation of V_(d)/V_(t)physiologic/alveolar or a surrogate to assess the degree of impairmentand the assessment of the degree of disturbance to the CO₂ stores wouldpermit the end-tidal CO₂ value to be determined and displayed withgreater confidence. FIG. 7, which is discussed in greater detail below,illustrates an exemplary process and apparatus for providing anindication of when end-tidal CO₂ is or is not a reliable/viable estimateof arterial CO₂.

The present invention also contemplates determining the degree ofphysiological impairment. Vd/Vt physiologic is preferably estimatedusing alveolar partial pressure of CO₂ (P_(A)CO₂) (per its definitionwithout the Enghoff modification). P_(A)CO₂ may be estimated byapplication of models to the volumetric capnogram as well as neuralnetworks, genetic algorithms, and other approaches or combination ofapproaches. U.S. Pat. No. 5,632,281 describes an approach for arterialestimation that may be used for alveolar estimation. VDalv/VTalv may beused as well and Hardman et al. describes a method for estimating thisratio.

The present invention also contemplates determining the degree ofdisturbance. The degree of disturbance or ventilatory stability can beassessed by different methods. For example, assessment of the degree ofdisturbance to the CO₂ stores may be determined by the measurement ofventilation (with the use of a model) to better determine periods of‘stability.’ Methods of estimating CO₂ stores may be found in U.S. Pat.No. 6,955,651 (“the '651 patent”), the contents of which areincorporated herein by reference. The tidal volume must be sufficientsize relative to the anatomic deadspace. Functional anatomic deadspacemay be estimated by methods known in the art such as Fowler's method.The reliability of the end-tidal value is further increased by applyingcriteria based on the expiratory flow rate for the breath from which theend-tidal measurement is taken. Application of these criteria will helpallow the determination of a reliable end-tidal value

As noted above, FIG. 7 illustrates an exemplary schematic embodiment ofa gas measurement system 100 according to the principles of the presentinvention. Gas measurement system 100 illustrates the components of asystem used to provide a reliable estimate of the end-tidalconcentration of a gas. The gas concentration or partial pressure values(used interchangeably) are determined by gas measurement component 110.This may be determined on a continuous or intermittent basis.Conventional gas concentration component provide data sampled atsampling rates from 25 to 100 samples/sec. Gas measurement component 110corresponds, for example, to gas sensor 14 and CO₂ signal unit 18 inFIG. 1 as discussed above.

Ventilation values measured at the airway or via other technologies aredetermined by ventilation measurement component 120. Ventilation valuesincludes, but are not limited to flow, volume, pressure, temperature,and humidity or any combination thereof. The ventilation values may bedetermined on a continuous or intermittent basis. Ventilationmeasurement component 120 corresponds, for example, to differentialpressure flowmeter 12 and flow signal unit 16. In an exemplaryembodiment, the ventilation related values are determined bymeasurements of flow, volume, or surrogates thereof. Surrogates of flowderived from acoustic measurements from external surface sensors fromcompanies, such as Andromed, are contemplated.

The gas concentration values from gas measurement component 110 andventilation measurement component 120 are received by the end-tidal gasmeasurement component 130. The present invention contemplatesimplementing end-tidal gas measurement component 130 via processing unit20 of FIG. 1. Characteristics of the received ventilation values areused by the end-tidal gas measurement component 130 to derive a morerobust end-tidal gas value from the gas concentration values. Forexample, changes in the received ventilation values indicating thechange from expiratory flow in the airway to inspiratory flow would beused to delineate in time the end of expiration. This may be obtainedfrom the values of the flow, volume or surrogates thereof. For flow, thetime of the zero crossing from expiratory flow (or zero flow in the caseof a pause interval) to inspiratory flow may be used. For volume, thetime from volume increasing (or flat) to decreasing may be used.Similarly, for acoustic measurements the change from expiratory toinspiratory flow can be determined by known methods.

Values from the ventilation measurement component 120 are also receivedby the ventilatory stability measurement component 140. The presentinvention also contemplates implementing ventilatory stabilitymeasurement component 140 via processing unit 20 of FIG. 1. Ventilatorystability may be determined by evaluating an historical record ofventilation values and assessing its stability. Time periods forassessment would vary based by the size of the gas stores of the gas inquestion. For CO₂ and O₂, the gas stores that would be considered areboth the lung and blood stores. The time interval that would be assessedwould be based upon size of those stores which could be estimated viamethods as disclosed the '651 patent as well as rules of thumb basedupon patient size. Exemplary methods of determining the variability ofthe ventilation values over the time period for assessment includeanalysis of the distribution of tidal volume values and, if a period ofsignificant hyperventilation or hypoventilation is observed during theassessment period, then the end-tidal value would be deemed lessreliable. The present invention also contemplates that the ventilatorystability measurement component 140 would receive values from the gasmeasurement component 110.

The estimates of ventilatory stability from the ventilatory stabilitymeasurement component 140 and the end-tidal values from end-tidalmeasurement component 130 are received by decision support system 150.The present invention further contemplates implementing decision supportsystem 150 via processing unit 20 of FIG. 1. Using these values as wellas other criteria, decision support system 150 determines thereliability of the end-tidal value. The reliability may be based simplyon a threshold of ventilatory stability and may be indicated on thedisplay of the host system numerically or graphically. The end-tidalnumber may be color coded to indicate its reliability such as red,yellow, green for unreliable, questionable, reliable, respectively.Based upon input from user or another system, decision support system150 may be configured as a rule based system. For example, patient ageas well as disease could permit physiological bounds (either fuzzy orhard bounds) to be used to indicate the reliability of the end-tidalvalue. It is also contemplated using measurement of Vd/Vt as notedearlier, in decision support system 150 to determine reliability of theend-tidal value. This could be simply an additional rule such as, in thecase of Vd/Vt physiologic, if Vd/Vt physiologic >0.70 then the end-tidalCO₂ value is highly unreliable as surrogate of arterial CO₂.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

1. A method of indicating the reliability of an end-tidal gas valuecomprising: measuring a plurality of gas concentration values; measuringa plurality of ventilation values; determining an end-tidal gas valuefrom the gas concentration values; determining the degree of ventilatorystability from the ventilation values; and providing an estimate ofreliability of the end-tidal gas values using the degree of ventilatorystability.
 2. The method of claim 1, wherein determining the end-tidalgas value is based, as least in part, on the ventilation values.
 3. Themethod of claim 2, wherein determining the end-tidal gas value includesapplying a mathematical relationship to the ventilation values and thegas concentration values.
 4. The method of claim 3, wherein themathematical relationship is a power regression.
 5. The method of claim1, wherein the gas concentration values measured are carbon dioxide,oxygen, nitrous oxide, nitric oxide, and anesthetic agents or anycombination thereof.
 6. The method of claim 1, wherein the ventilationvalues measured are flow, volume, pressure, temperature, and humidity orany combination thereof.
 7. A method of indicating the reliability of anend-tidal gas value comprising: measuring a plurality of gasconcentration values; measuring a plurality of flow values; determininga plurality of volume values from the flow values; determining anend-tidal gas value from the gas concentration values; determining thedegree of ventilatory stability from the flow values and volume values;and providing an estimate of reliability of the end-tidal gas valuesusing the degree of ventilatory stability.
 8. The method of claim 7,wherein determining the end-tidal gas value is based, as least in part,on the ventilation values.
 9. The method of claim 8, wherein determiningthe end-tidal gas value includes applying a mathematical relationship tothe ventilation values and the gas concentration values.
 10. The methodof claim 9, wherein the mathematical relationship is a power regression.11. The method of claim 7, wherein the gas concentration values measuredare carbon dioxide, oxygen, nitrous oxide, nitric oxide, and anestheticagents or any combination thereof, and wherein the ventilation valuesmeasured are flow, volume, pressure, temperature, and humidity or anycombination thereof.
 12. An apparatus for improving reliability of anend-tidal gas value comprising: means for sensing a plurality of gasconcentration values; means for sensing a plurality of ventilationvalues; means for determining an end-tidal value from the gasconcentration values; means for determining the degree of ventilatorystability from the ventilation values; and means for providing anestimate of reliability of the end-tidal gas values using the degree ofventilatory stability.
 13. The apparatus of claim 12, wherein the meansfor determining an end-tidal value determines the end-tidal gas valuebased, as least in part, on the ventilation values.
 14. The apparatus ofclaim 13, wherein the means for determining the end-tidal gas valueapplies a mathematical relationship to the ventilation values and thegas concentration values.
 15. The apparatus of claim 14, wherein themathematical relationship is a power regression.
 16. The apparatus ofclaim 12, wherein the gas concentration values measured are carbondioxide, oxygen, nitrous oxide, nitric oxide, and anesthetic agents orany combination thereof, and wherein the ventilation values measured areflow, volume, pressure, temperature, and humidity or any combinationthereof.
 17. An apparatus for determining an end-tidal gas valuecomprising: means for sensing a plurality of gas concentration values;means for sensing a plurality of ventilation values; and means fordetermining an end-tidal value from the gas concentration values and theventilation values using a mathematical relationship.
 18. The apparatusof claim 17, wherein the means for determining the end-tidal gas valuedetermines the end-tidal gas value based, as least in part, on theventilation values.
 19. The apparatus of claim 17, wherein the gasconcentration values measured are carbon dioxide, oxygen, nitrous oxide,nitric oxide, and anesthetic agents or any combination thereof, andwherein the ventilation values measured are flow, volume, pressure,temperature, and humidity or any combination thereof.